Debaty 2014.
Methods | Parallel‐group, randomized trial, February 2009 to August 2012, multicentre study | |
Participants | Total number of participants 245, mean age 67 years, 29% female, patients' average temperature at randomization: pre‐hospital cooling group 35.2°C, hospital cooling group: 35.4°C (estimated from graph) Inclusion criteria:
Exclusion criteria:
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Interventions | Intra‐arrest cooling, infusion of up to 2000 mL of ice‐cold 0.9% saline solution at 100 mL/min during cardiac arrest by use of a standard infusion set and a pressure bag inflated to 300 mmHg. Surface cooling was also induced using gel pads. | |
Outcomes | Types of outcome measures: Primary outcomes
Secondary outcomes
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Funding | French Society of Emergency Medicine | |
Declarations of interest | None | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization assignments were generated under a randomized permuted‐block design, with block sizes of 4, in a 1:1 allocation |
Allocation concealment (selection bias) | Low risk | Each mobile intensive care unit was given sequentially numbered, sealed envelopes containing single randomization assignments |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided |
Blinding of outcome assessment (detection bias) Good neurological outcome | Low risk | Neurological outcome at hospital discharge and 30 days was assessed by a physician blinded to the study allocation |
Blinding of outcome assessment (detection bias) Survival | Low risk | Lack of blinding of survival data considered 'low risk' |
Blinding of outcome assessment (detection bias) Adverse events | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Analysis of clinical outcomes was according to intention‐to‐treat |
Selective reporting (reporting bias) | Low risk | All expected outcomes included |
Other bias | Unclear risk | No information on application of pre‐hospital cold fluids (which proportion of patients received how much) Over 24 hours of cooling the body temperature of the intra‐arrest cooling group seemed to be higher than the body temperature of the hospital cooling group According to the authors the study was not powered to show a clinical difference |